Note d’appui de l’Anses pour la conduite de l’évaluation des substances naturelles à usage biostimulant

The French agency Anses will be in charge of the set up of evaluation criteria for natural substances with biostimulant use, as defined in Decree No. 2016-532 of 27th April 2016 related to the procedure of authorization of natural substances with biostimulant use (More information). These criteria will allow Anses to review the substances candidate and authorized substances will be included on a list published by the Ministry of Agriculture. To this date, only medicinal plants or parts of plants included in the pharmacopoeia are authorized (More information).

Anses will look into existing regulations in order to set up the evaluation criteria to include new substances. So far, only the criteria required to apply for an authorization of placing on the market (AMM) of a fertilizer, including biostimulants, allows to ensure the absence of adverse effect on human and animal health and the environment, under the claimed conditions of use.

Staphyt regulatory has experience in the constitution and submission of biostimulant dossiers applications in France. At European level, Staphyt regulatory closely follows the setting up of evaluation methods for biostimulants by taking part of the European technical committee on plant biostimulants and agricultural microorganisms, named CEN/TC 455, which will define the evaluation methods for these products under the future regulation for EC fertilisers including biostimulants.

Contact our expert Myriam Eck if you wish to know more about french regulation for biostimulants.